On May 6, 2025, with almost no discernible press or public announcements, the Dental Trade Alliance (DTA) – a trade association of dental suppliers and service providers – issued a revised and restated U.S. Code of Ethics (the “Code”). Unlike traditional medical device sectors, there is not a significant amount of dental industry-specific compliance guidance designed to address healthcare fraud and abuse considerations. The DTA’s revised Code provides greater clarity around compliance considerations for how dental supply and device industry companies should interact with dental care providers and other stakeholders.
The DTA Code specifies that “[a]ll dental manufacturers and distributors should review and understand and adopt [the DTA Code],” or another code designed to address similar issues. The DTA Code highlights that companies are also expected to review and comply with other codes that exist “outside the limits of the DTA’s jurisdiction” like the AdvaMed Code, MEDEC Code, PhRMA Code, and the Anti-Kickback Statute. The DTA Code also couches its provisions as intended to help companies comply with U.S. Department of Health & Human Services Office of Inspector General (“OIG”) expectations; and it incorporates similar principles outlined in the AdvaMed Code of Ethics – the medical device industry code of ethics equivalent.
Put another way, the DTA Code is not intended to establish new mandatory obligations, but it encourages companies to take steps (like adopting relevant industry standards or implementing effective monitoring programs) towards enhanced compliance.
The DTA Code also provides distinct, industry-specific guidance tailored to the dental sector, including practical considerations for hands-on clinical training, co-travel arrangements, and the unique dynamics of relationships between oral health manufacturers and distributors, as highlighted below.
1. Interactions with Dental Professionals
The DTA Code provides guidance for appropriate interactions between dental companies (manufacturers, distributors, laboratories, and the associates of those companies) and dental professionals (dentists, dental hygienists, dental assistants, and laboratory technicians). It emphasizes what the industry considers to be appropriate conduct during co-travel visits (i.e., when a manufacturer works side-by-side with a distributor representative to visit dental professionals in a dental office), in-office demonstrations, training programs, business meetings, and other interactions. More specifically:
- Company-Conducted Training and Education. Training and education on company products “should be conducted in settings that are conducive to the effective transmission of information.” The Code provides examples of where programs providing “hands on” training should occur.
- Modest Meals. Companies may provide dental professional attendees with modest meals and refreshments in connection with educational programs or other business interactions involving the presentation of clinical or business information. The Code offers additional guidance on appropriate settings for such meals and the types of participants who may be invited.
- Sponsored Travel for Education Purposes. When there are objective reasons to support out-of-town travel to efficiently deliver training and education on dental products and technologies, companies may pay for the reasonable travel and modest lodging costs of dental professionals.
- Gifts and Entertainment. A company may provide items to dental professionals that directly benefit patients or serve a legitimate educational purpose, provided such items (excluding textbooks or anatomical models) have a fair market value under $100. Personal-use items or those unrelated to education or patient care are prohibited. Additionally, the DTA Code states that, to avoid the appearance of impropriety, a company should not provide or pay for any entertainment or recreational event or activity for any dental professional.
- Demonstration Products/Samples. The DTA Code provides certain circumstances where a company may provide reasonable quantities of products to dental professionals at no charge for evaluation and demonstration purposes.
2. Key Opinion Leaders, Speakers, and Continuing Education Sponsorship
The DTA Code includes detailed considerations for how dental manufacturers and other member companies may engage with dental professionals for important consulting and advisory services, to conduct company education, and to participate in industry-sponsored events. The DTA Code is intended to help companies design interactions with key opinion leaders and other HCPs as grounded in legitimate business needs, conducted transparently, and aligned with applicable legal and ethical standards. More specifically:
- Consulting Arrangements. The DTA Code requires companies to engage dental professionals for consulting services only when there is a documented, legitimate business need. Permissible consulting services may include research, product development, intellectual property development and support, speaking engagements, advisory board participation, and training. All such arrangements must be governed by written agreements that clearly describe the services to be provided and include fair and reasonable market value compensation. Selection of consultants must be based on the individual’s qualifications and expertise, not on their ability to generate business.
- Expenses and Settings. The DTA Code requires that any expenses reimbursed to consultants – including travel, meals, and lodging – be reasonable, necessary, and modest in value. Meetings with consultants must be held in appropriate clinical, educational, or other professional settings, or conducted virtually where feasible. Meals and refreshments provided in connection with such meetings must be secondary in time and focus to the meeting’s business purpose.
- Transparency. To promote transparency, the DTA Code requires that dental professionals who receive compensation from companies as speakers or consultants disclose this relationship to their audiences. While company sales personnel may suggest candidates for consulting roles, the DTA Code requires that they not control or unduly influence the selection process.
- CE Sponsorships. The DTA Code permits companies to support independent continuing education (CE) events, including those sponsored by dental associations and accredited CE providers. Companies may provide educational grants to conference sponsors or institutions, provided the sponsor selects attendees and controls the use of funds. The Code requires that these conferences be primarily focused on objective scientific and educational content.
- Advertising and Education. The DTA Code permits companies to lease booth space and place advertisements at conferences. It also encourages members to offer educational programs that support the appropriate clinical use of their products, provided those programs meet applicable transparency, independence, and disclosure requirements.
3. The Relationship between Manufacturers, Distributors, and Dental Professionals
The DTA Code outlines expectations for interactions among manufacturers, distributors, laboratories, service providers, and the dental community.
- Appreciation Events. The DTA Code does acknowledge that companies may conduct “Customer Appreciation” events (which does not appear to be defined) but it also requires that distributors and manufacturers adhere to applicable legal requirements and that these events are carried out with an appropriate level of professionalism.
- Customer Needs. Distributors are expected to understand and prioritize the specific needs of their dental customers, recognizing that practices vary widely in size, goals, and service models.
- Product Training. Manufacturers may offer training programs to distributors, and in fact should ensure that distributors are adequately trained and supported on their products, with particular attention paid to new product launches. Training should be focused on professional, clinical, and patient-centered information exchange. These should be conducted in a professional setting and focused on information exchange rather than social interaction.
- Direct Sellers. Manufacturers that sell directly to dental professionals are expected to uphold the same ethical standards as traditional distributors, including providing service and support that facilitates the effective use of new products and technologies.
4. Applicable Laws and Statutes
The final chapter of the Code provides a general overview of applicable laws, specifically referencing the U.S. Physician Payments Sunshine Act / Open Payments reporting requirements and the federal Anti-Kickback Statute, and incorporating a link to the HHS OIG’s educational materials for physicians on federal fraud and abuse laws.
Conclusion
The DTA Code reflects evolving compliance expectations across the medical and dental products industries and their various sectors. These updated standards reinforce a continued focus on ethical interactions between dental product manufacturers, suppliers, and distributors and dental care professionals across the U.S.
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